Director, Global Safety – Global Periodic Aggregate Safety Reports

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $191.1k - $258.5k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Develop Pharmacovigilance Operations strategy for the production and submission of periodic aggregate safety reports (PASRs) • Oversee all aspects of PASRs and periodic reporting processes, schedules, outputs, and metrics throughout the product life cycle • Lead a global team with members in the US/EU and Amgen India • Participate in cross-functional activities to ensure compliance and consistency with PASR preparation for all Amgen products • Provide global leadership for the PASR team and ensure regulatory requirements are met • Develop and maintain the Global Periodic Reports Schedule, Standards and Procedures • Liaise between external vendors, Global Patient Safety, and cross-functional teams in creating PASRs • Undertake activities delegated by the QPPV as detailed in the PV System Master File • Maintain inspection readiness • Serve as point of contact for Health Authority Inspections and Internal Process Audits • Manage global staff in the functional area

🎯 Requirements

• Doctorate degree and 4 years of Global Safety experience, OR Master’s degree and 8 years of Global Safety experience, OR Bachelor’s degree and 10 years of Global Safety experience • At least 4 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources • Experience in Pharmacovigilance Operations and periodic aggregate safety reports (PASRs) • Knowledge of global regulatory requirements and compliance policies and standards • Ability to maintain inspection readiness • Sponsorship for this role is not guaranteed

🏖️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance • Reasonable accommodations for applicants and employees with disabilities